Injectafer

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmerican Regent, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0517065001
1 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-01) / 15 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

6897GXD6OE

FERRIC CARBOXYMALTOSE

RxCUI 1433693

Orange Book

N203565

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6897GXD6OE",
    "rxcui": "1433693",
    "inchikey": null,
    "display_name": "FERRIC CARBOXYMALTOSE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "517b4a19-45b3-4286-9f6a-ced4e10447de": {
      "match": "brand_token",
      "title": "INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION INJECTAFER (FERRIC CARBOXYMALTOSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.]",
      "spl_version": "29",
      "published_date": "2025-01-08"
    }
  },
  "productid": "0517-0650_a092ebb6-505b-464f-9669-194a913ff8e5",
  "productndc": "0517-0650",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203565",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "750MG IRON/15ML (50MG IRON/ML)",
        "product_no": "001",
        "approval_date": "Jul 25, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "500MG IRON/10ML (50MG IRON/ML)",
        "product_no": "002",
        "approval_date": "Oct 8, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1GM IRON/20ML (50MG IRON/ML)",
        "product_no": "003",
        "approval_date": "Apr 28, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG IRON/2ML (50MG IRON/ML)",
        "product_no": "004",
        "approval_date": "Feb 4, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FERRIC CARBOXYMALTOSE",
  "proprietary_name": "Injectafer",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA203565",
  "marketing_category": "NDA",
  "nonproprietary_name": "Ferric Carboxymaltose Injection",
  "start_marketing_date": "20130812",
  "active_numerator_strength": "50"
}

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